REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1508 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.

NCT01293734

Bronchial Asthma

COMPLETED PHASE2

Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma

NCT04128111

Bronchial Asthma

UNKNOWN

REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)

NCT06220019

Pneumonia

NOT_YET_RECRUITING

Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

NCT02937207

Bronchial Asthma

UNKNOWN PHASE2

Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease

NCT01486186

Pulmonary Disease, Chronic Obstructive

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Bronchial asthma is characterized by chronic inflammation of the airways, which is often recurrent, long-lasting and difficult to cure. Clinical studies have confirmed that the clinical symptoms and quality of life of asthma patients have been significantly improved after TCM intervention. However, most of the current clinical research methods on asthma are small-sample and RCT studies, resulting in insufficient demonstration of efficacy, and there is an urgent need to carry out multi-center, large-sample, high-quality real-world studies in order to obtain higher quality evidence-based medical evidence.

This is a multi-center, large-sample prospective cohort study, which will evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and provide high-quality evidence for the promotion and application of TCM syndrome differentiation therapy in bronchial asthma. The cohort study will enroll 1508 patients, and the standard use of TCM treatment regimen will be set as the TCM cohort group, and those who will use the conventional treatment of Western medicine but not the standard TCM treatment regimen will be the non-TCM cohort group. The asthma control rate was the main outcome index, and the asthma control questionnaire (ACQ), asthma quality of life score (AQLQ), clinical symptom and sign score, lung function, exhaled nitric oxide, induced sputum inflammation phenotype, glucocorticoid dose, and fast-acting β2 agonist dose were the secondary outcome indicators. Follow-up was conducted every 3 months for 1 year.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchial Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traditional Chinese Medical cohort

The standardized use of TCM treatment regimen was regarded as an exposure factor, and the treatment methods of the enrolled patients were defined and grouped: patients who took medication continuously for more than 3 months per year, or who took medication intermittently for more than 6 months in the total time of the year, were in the exposure group.

No interventions assigned to this group

Non Traditional Chinese Medical cohort

Those who used conventional Western medicine treatment without using standardized Chinese medicine treatment regimen were in the non-exposure group.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients who meet the diagnosis of bronchial asthma;
2. Age 18\~80 years old;
3. Have not participated in other clinical studies within 1 month before enrollment;
4. Voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria

1. Patients with respiratory failure and mechanical ventilation during acute asthma exacerbation;
2. Delirium, impaired consciousness, dementia, and various mental illnesses;
3. Patients with other lung diseases such as COPD, lung abscess, cystic fibrosis, bronchiectasis, etc., and severe liver and kidney diseases;
4. Patients with neuromuscular diseases that affect respiratory motor function and are unable to complete the six-minute walk test;
5. Pregnant and lactating patients;
6. Those who are participating in other clinical trials.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No